- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03893695
Combination of GT90001 and Nivolumab in Patients With Metastatic Hepatocellular Carcinoma(HCC)
Combination of GT90001 and Nivolumab in Patients With Metastatic Hepatocellular Carcinoma
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Locations
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Tainan, Taiwan
- National Cheng Kung University Hospital
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Taipei, Taiwan
- Mackay Memorial Hospital
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Taipei, Taiwan
- National Taiwan University Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Be willing and able to provide written informed consent for the trial;
- Age ≥20 years male and female;
Subjects must have confirmed diagnosis of unresectable HCC with any of following criteria:
i. Histologically or cytologically confirmed diagnosis of HCC ii. Have Barcelona Clinic Liver Cancer (BCLC) Stage C disease or BCLC Stage B disease not amenable to locoregional therapy or refractory to locoregional therapy;
- Have documented disease progression or intolerance after first-line systemic treatment;
- At least one measurable lesion based on RECIST version 1.1 ;
- Child-Pugh score ≤ 6 (Child-Pugh A)score within 7 days of first dose of study drug;
- ECOG performance status: 0-1;
- Have a predicted life expectancy of greater than 3 months;
The functions of the important organs are confirmed with the following requirement:
- Hemoglobin (HGB) ≥ 90 g/L;
- White blood cell count (WBC) ≥ 3×10^9/L;
- Absolute neutrophil count (ANC) ≥ 1.5×10^9/L;
- Platelets (PLT) ≥ 100×10^9/L;
- Total bilirubin (TBIL) ≤ 1.5× Upper limit of normal value (ULN)
- Aspartate aminotransferase (AST), alkaline phosphatase (ALP), and alanine aminotransferase (ALT) ≤ 5× ULN
- Creatinine (Cr) ≤ 1.5×ULN;
- International normalization ratio (INR)or prothrombin time (PT) ≤ 1.5×ULN ;
- Women must have a negative serum or urine pregnancy test within 72 hours prior to the start of investigational product;
- Women of childbearing potential must agree to contraception for the duration of study treatment and 5 months after the last dose of study treatment;
- Willing and able to comply with all aspects of the protocol
Exclusion Criteria:
Imaging findings for HCC corresponding to any of the following:
- HCC with ≥ 50% liver occupation
- Clear invasion into the bile duct
- Portal vein invasion or thrombosis at the main portal branch (Vp4)
- Gastric or esophageal varices that require treatment;
- If prior history of DVT/PE, the patient needs to be on stable doses of anticoagulation with low molecular weight heparin or oral anticoagulant for at least two weeks;
- Esophageal vein dilation, grade A of active peptic ulcer rating, and all bleeding risk by gastroscopy;
- History of arterial thromboembolic event in past 6 months;
- Active bleeding disorder, including gastrointestinal bleeding event or active hemoptysis within 28 days prior to study treatment;
- Have central nervous system (CNS) metastases;
- Has a known history of human immunodeficiency virus (HIV);
- Has received prior immune checkpoint inhibitor (including those targeting PD-1, PD-L1 or PD-L2, CD137, or cytotoxic T-lymphocyte antigen [CTLA-4]);
- Has a known history of, or any evidence of, interstitial lung disease or active non- infectious pneumonitis;
- Has active autoimmune disease that has required systemic treatment in past 2 years;
- Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial;
- Any history of drug or alcohol dependency or abuse within the prior 1 years;
- Has known active Hepatitis B or Hepatitis C within 2 weeks prior to initiation of study treatment Note: Patients with HBV infection are required to be receiving effective antiviral therapy over two weeks, and then have continuous therapy in study period;
- Pregnant, breast feeding, or planning to become pregnant;
- Have a history of severe hypersensitivity reaction to monoclonal antibody;
- Significant cardiovascular impairment: history of congestive heart failure greater than New York Heart Association (NYHA) Class II, unstable angina, myocardial infarction or stroke within 6 months of the first dose of study drug;
- Have surgery, radiotherapy, ablation within one month before screening;
- Subjects with any other serious disease considered by the investigator not in the condition to enter into the trial
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: metastatic HCC
Stage one - Dose de-escalation: Each dose cohort will assess toxicity within the 28 days following the first dose of nivolumab and GT90001. Stage two- the expansion cohort: 14 patients will be enrolled to the expansion cohort where one or no DLT takes place in planned study cohort. |
Stage1:Dose de-escalation.
Stage2:the expansion cohort where one or no DLT takes place in planned study cohort.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Dose-limiting Toxicity(DLT)
Time Frame: 28 days
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Each dose cohort will initially include 6 evaluable patients for assessment of toxicity within the 28 days following the first dose of nivolumab and GT90001.
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28 days
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
overall response rate (ORR)
Time Frame: 2 years
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To estimate ORR, per RECIST 1.1 assessed by investigator review
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2 years
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the duration of response (DOR),
Time Frame: 2 years
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To evaluate the DOR per RECIST 1.1 assessed by investigator review
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2 years
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disease control rate (DCR),
Time Frame: 2 years
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To evaluate the DCR per RECIST 1.1 assessed by investigator review
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2 years
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time to response (TTR)
Time Frame: 2 years
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To evaluate the TTR per RECIST 1.1 assessed by investigator review
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2 years
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progression-free survival (PFS)
Time Frame: 2 years
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To evaluate the PFS per RECIST 1.1 assessed by investigator review
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2 years
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maximum concentration (Cmax)
Time Frame: 2 years
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Pharmacokinetics
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2 years
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time that maximum concentration is observed (tmax)
Time Frame: 2 years
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Pharmacokinetics
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2 years
|
area under the concentration time-curve from time zero to infinity (AUC0∞)
Time Frame: 2 years
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Pharmacokinetics
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2 years
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area under the plasma concentration-time curve from time zero hours to time (t hrs), (AUC0-t)
Time Frame: 2 years
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Pharmacokinetics
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2 years
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area under the plasma concentration-time curve from time zero hours to 24 hours (AUC0-24)
Time Frame: 2 years
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Pharmacokinetics
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2 years
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terminal elimination rate constant (λz)
Time Frame: 2 years
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Pharmacokinetics
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2 years
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terminal elimination half life (t½)
Time Frame: 2 years
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Pharmacokinetics
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2 years
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volume of distribution (Vz)
Time Frame: 2 years
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Pharmacokinetics
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2 years
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volume of plasma cleared of the drug per unit time (C)
Time Frame: 2 years
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Pharmacokinetics
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2 years
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Exploratory Biomarker: circulating tumor deoxyribonucleic acid (ctDNA)
Time Frame: 2 years
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HCC-related pathway alterations including VEGF and TGF-β pathway genes
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2 years
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Collaborators and Investigators
Investigators
- Study Director: Yuwei Xu, Suzhou Kintor Pharmaceuticals,inc.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Adenocarcinoma
- Neoplasms, Glandular and Epithelial
- Digestive System Neoplasms
- Liver Diseases
- Liver Neoplasms
- Carcinoma
- Carcinoma, Hepatocellular
- Molecular Mechanisms of Pharmacological Action
- Antineoplastic Agents
- Antineoplastic Agents, Immunological
- Immune Checkpoint Inhibitors
- Nivolumab
Other Study ID Numbers
- GT90001-TW-1001
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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